Resources

• Glass Delamination: Risks, Reality and Regulatories
  Daniele Zuccato, Nuova OMPI - Stevanato Group, December 6, 2012
• FDA Perspective: Risk Based Cleaning, Sanitization, and Sterilization
  Michael Klapal, US FDA, April 3, 2012
• Sterilization: A to Z
  James Agalloco, Agalloco & Associates, April 3, 2012
• Microbiological Considerations for Non-Sterile Pharmaceutical Products
  Dr. Leonard Mestrandrea, Mestrandrea Consulting, April 3, 2012
• Thinking About Risk and Endotoxin Control
  Karen Zink McCullough, MMI Associates, April 3, 2012
• Disinfection Processes
  Jim Polarine Jr., MA, Steris Corp., April 3, 2012
• Cleaning Processes and Microbial Controls
  Rebecca Brewer, Dober, April 3, 2012
• ICH Q11 - Development and Manufacture of Drug Substances
  Betsy Fritschel, International Conference on Harmonisation, March 7, 2012
• Preservative Formulation and Effectiveness in Oral Solutions and Suspensions
  Hang Guo and Chris Knutsen, PhD, Bristol-Myers Squibb, February 15, 2012
• FDA Enforcement Update
  Joseph F. McGinnis, R.Ph, September 28, 2011
• FDA's Guidance for Industry: Process Validation
  Scott Bozzone, Phil DeSantis, Jim Agalloco, June 8, 2011
• Sterile Product Package Integrity Testing
  Current Practice, Common Mistakes, New Developments. By Dana Morton Guazzo, PhD, May 17, 2011
• Regulatory Perspective on Key USP General Chapters in aMicrobiology
  Dennis E. Guilfoyle, Ph.D., September 23, 2010
• Microbiology Best Laboratory Practices
  Xiaoming Wang, April 6, 2010
• Current Trends in Process Validation: The New Paradigm
  Ellen Moskowitz, April 6, 2010
• Preliminary Audit to a Pre-Approval Inspection
  Robert D. Seltzer, April 6, 2010
• 483s-Not Here
  Joel Schwartzman, April 6, 2010
• USP Activities Impacting Sterilization & Sterility Assurance
  James Agalloco, April 6, 2010
• Overview of Pre-Approval Inspections
  Kelli F. Dobilas, April 6, 2010
• STATE OF THE PHARMACEUTICAL INDUSTRY
  Presented October 1, 2009 at the PDA Metro Chapter Vendor Show & FDA Night
• GMPs for the 21st Century; A Risk-Based Approach, Steven Ostrove (2953 KB)
• Risk-Based Validation and Requalification of Processes & Equipment, Nancy Tomoney (1852 KB)
• A Risk-Based Model for Choosing in Process Testing Sites, Karen McCullough (180 KB)
• Mitigating Raw Materials Risk for Supply Chain Continuity, Tom Dinka (1028 KB)
• Assessing the Risk of Objectionable Microorganisms, Frank Settineri (427 KB)
• Using Risk Management To Put the "Design" in "QbD", William Bennett (514 KB)
• Team Biologics Inspection Approach
  Anne Marie Montemurro, May 2009 (159 KB)
• Canadian Pharmaceutical GMP, Richard Pike (184 KB)
• Cold Chain Shipping - Protecting Temperature Sensitive Products, Diane McLean (1.02 MB)
• Disaster Recovery & Business Continuity - related, but NOT the Same!, Teri Stokes, PhD (699 KB)
• End User Testing for Performance Qualification of GXP Part 11 Systems - Off the Shelf (OTS), Teri Stokes, PhD (637 KB)
• FDA API Inspections, Robert Horan, PhD (500 KB)
• Regulatory Perspective on Key USP General Chapters in aMicrobiology
  Dennis E. Guilfoyle, Ph.D., September 23, 2010
• FDA Inspectional Approach, Paul Bellamy (733 KB)